IntellO2 vs Manual Control for Optimizing Oxygenation in Infants

June 25, 2018 updated by: Vapotherm, Inc.

Comparison of the IntellO2 - Precision Flow Automatic FiO2 Controller to Manual Control for Optimizing Oxygenation in Preterm Infants Receiving High Flow Nasal Cannula Therapy

The overall objective of this study is to demonstrate that the IntellO2 device providing automated control of fraction of inspired oxygen (FiO2) adjustments in spontaneously breathing infants with fluctuating arterial blood oxygen saturation levels is safe and efficacious in the routine clinical environment. Specifically, it is hypothesized that the IntellO2 will perform as well or better than standard practice for maintaining infants' arterial blood oxygen saturation in a target range while minimizing the exposure to elevated levels of oxygen in the inspired gas.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Trust
    • Surrey
      • Chertsey, Surrey, United Kingdom, KT16 0QA
        • Ashford and St. Peter's Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Preterm infants being treated with high flow nasal cannula therapy
  2. A need for supplemental oxygen as demonstrated by an required FiO2 > 0.25 at enrollment
  3. Requiring a flow rate of greater than 2 L/min such that the assumed inspired oxygen fraction matched delivered oxygen fraction (definition of HFNC).

Exclusion Criteria:

  1. Major congenital abnormalities
  2. Hemodynamic instability, defined as being outside of a normotensive range based on each infant's individual characteristics
  3. Seizures
  4. Ongoing sepsis
  5. Meningitis
  6. Clinician's concern regarding stability of the infant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IntellO2
Automated control of FiO2
Device: IntellO2
Automated FiO2 regulator that responds to pulse oximetry measures
ACTIVE_COMPARATOR: Manual
Manual control of FiO2
Other: Manual control
Standard practice of manually titrating FiO2 as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent time in target range for oxygen saturation by pulse oximetry
Time Frame: 24 hrs
24 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vapotherm, Inc.

Collaborators

Oxford University Hospitals NHS Trust
Ashford and St. Peter's Hospitals NHS Trust

Investigators

  • Principal Investigator: Peter Reynolds, MB.BS PhD, Ashford and St. Peter's Hospitals NHS Trust
  • Study Director: George C Dungan, MPhil, Vapotherm, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2016

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

January 1, 2018

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

February 26, 2014

First Posted (ESTIMATE)

February 28, 2014

Study Record Updates

Last Update Posted (ACTUAL)

June 27, 2018

Last Update Submitted That Met QC Criteria

June 25, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RP-NIAE2014001Reg

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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